Successful Clinical Trial of Type 2 Drug That Works on Intestinal Organisms

BROOMFIELD, Colo.–MicroBiome TherapeuticsTM has announced positive results from its clinical trial of a microbiome modulator, NM504, in development for type 2 diabetes and pre-diabetes.

NM504 is designed to improve glucose tolerance and other metabolic parameters in patients with diabetes by shifting the gastrointestinal microbiome–the micro-organisms that inhabit the human body.

Studies have shown that people with type 2 diabetics typically have gastrointestinal dysbiosis, or microbial imbalances, that may contribute to the metabolic dysfunction associated with the condition.

The double-blind, randomized, placebo-controlled trial assessed whether NM504 administered for four weeks could improve the glucose tolerance of subjects with pre-diabetes and untreated type 2 diabetes by modulating the gastrointestinal microbiome. The study enrolled 42 subjects.

Top-line results show that twice-daily oral administration of NM504 reduced postprandial serum glucose levels and increased insulin sensitivity in these subjects. The results were statistically significant as measured by an oral glucose tolerance test. NM504 also decreased markers of chronic inflammation and blood lipids in treated subjects, and it decreased appetite as determined by a validated physician-administered scale. NM504 was well tolerated and patient compliance was excellent.

“This trial represents a milestone both for MBT and the emerging field of microbiome therapy,” noted Steve Orndorff, CEO of Microbiome Therapeutics. “NM504 is the first therapeutic shown to directly modulate the GI microbiome in diabetics, and this study is among the first randomized, placebo-controlled trials of a microbiome-based therapy to achieve a statistically significant medical outcome. We look forward to reporting more detailed data on this study at upcoming scientific meetings.”

NM504 is also being studied in a placebo-controlled, double-blinded, proof of concept trial testing its utility in combination with metformin in type 2 diabetes patients with adverse gastrointestinal effects. In a recently-published case study (http://wageningenacademic.metapress.com/content/FG7642372U410742), NM504 demonstrated the potential to mitigate the GI side effects associated with metformin.

MBT is developing microbiome modulators that alter microbial populations and their environment in the gastrointestinal tract to address serious health conditions. The company’s microbiome modulators are designed to act on multiple factors, augmenting the growth of targeted desirable bacterial strains and discouraging the growth of others. NM504 is formulated to promote microbiome shifts that positively affect metabolism and weight.

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